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CTRI Number  CTRI/2025/05/086495 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 06/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   study on siddha medicine manjal noi kudineer for treating anemia in children  
Scientific Title of Study   An open clinical trial to evaluate the effectiveness of siddha herbal formulation Manjal noi kudineer for the management of Paandu noi (Iron Deficiency Anemia) in children among out-patients attending Ayothidass Pandithar Hospital, National Institute Of Siddha.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr N Sabana yasmine 
Designation  PG SCHOLAR 
Affiliation  Natioal Institute Of Siddha 
Address  Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute Of Siddha, Tambaram Sanatorium,Chennai-47, kancheepuram.

Kancheepuram
TAMIL NADU
600047
India 
Phone  09600876457  
Fax    
Email  sabanayasmine2020@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr N Sabana yasmine 
Designation  PG SCHOLAR 
Affiliation  Natioal Institute Of Siddha 
Address  Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute Of Siddha, Tambaram Sanatorium,Chennai-47, kancheepuram.

Kancheepuram
TAMIL NADU
600047
India 
Phone  09600876457  
Fax    
Email  sabanayasmine2020@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Suresh  
Designation  Professor 
Affiliation  Natioal Institute Of Siddha 
Address  Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute Of Siddha, Tambaram Sanatorium,Chennai-47, kancheepuram.

Kancheepuram
TAMIL NADU
600047
India 
Phone  9962571137  
Fax    
Email  drsureshherbal@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Siddha, Tambaram Sanatorium, Chennai-47 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room no 16/17, Department of Kuzhandhai Maruthuvam, National Institute Of Siddha,Tambaram Sanatorium, Chennai-47,Kancheepuram 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr N Sabana yasmine  Ayothidoss Pandithar Hospital  Room no 16/17, Department of kuzhanthai Maruthuvam,National Institute of Siddha, Tambaram Sanatorium,Chennai-47
Kancheepuram
TAMIL NADU 
9600876457

sabanayasmine2020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Manjal noi kudineer   Adult dose 85 ml For children dose will be given according to weight of the child using Clarks rule 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Hemoglobin level within 8.0-10.9gm 
 
ExclusionCriteria 
Details  Patient with chronic disease
Known case of any hematological disorder 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The clinical study will be assessed by increase of hemoglobin level in before and after treatment
For clinical significance defined as the MCID of hemoglobin increase from the baseline.
Reduction of clinical symptoms like malaise, headache, palpitation, lack of concentration during before and after treatment. 
18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of clinical symptoms like malaise, headache, palpitation, lack of concentration during before and after treatment.  18 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   04/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

BACKGROUND: Iron deficiency anemia (ICD -11:3A00, ISMT-4.7.40)) is a significant public health problem that occurs worldwide in both developed and developing countries. In 1980, the World Health Organization (WHO) estimated that 700 million people worldwide suffered from anemia and more than two billion people worldwide have been affected by it. Approximately 50% of anemia cases are caused by iron deficiency.  Iron deficiency anemia (IDA) is the most frequent hematological disorder of childhood and adolescence and the most common form of anemia, with an incidence in industrialized countries of 20.1% between 0 and 4 years of age and 5.9% between 5 and 14 years (39 and48.1% in developing countries) . It is a hypochromic and microcytic anemia characterized by Hb values below the normal range for sex and age, reduced MCV, and MCH. Iron is an essential nutrient for the development of the fetus, infant, and child . The body’s iron content is dependent on its intake and absorption with nutrition. The homeostasis of this nutrient is determined by the balance between its uptake and release from the cells where it is stored and recycled . Iron is released into the circulation where it is carried by the plasma protein transferrin, into the duodenum by enterocytes that absorb dietary iron, and by macrophages which recycle senescent erythrocytes and liver reserves. If iron levels in the body are inadequate, its intestinal absorption is enhanced [6]; In case of excess, it is stored in the enterocytes as ferritin and the liver, spleen, and bone marrow as hemosiderin. The release of free iron ions in the plasma, essential for the maintenance of its homeostasis, is mediated by ferroportin, whose expression is subordinated to the activity of hepcidin. WHO criteria for diagnosis of IDA: Age 6 months - 6 yrs: less than 11 gms, Age 6 yrs - 14 yrs : less than 12 gms. Mild: Hemoglobin 10.0 g/dL to lower limit of normal. Moderate: Hemoglobin 8.0 to 10.9 g/dL. Severe: Hemoglobin 6.5 to 7.9 g/dL. According to the Siddhar Yugi muni the diseases are widely classified into 4448 including Veluppu noi also. The term Veluppu denots the pallor of the body. Veluppu is described as a diseased condition in which the nature of the body including nail beds and conjunctiva becomes pallor. As per siddha concept Veluppu noi occurs due to excessive intake of salt and sour taste,fever, vomiting, diarrhoea, worms, liver diseases and intake of unconsumed items such as soil,ash and camphor. Iron deficiency causes different abnormalities in the three major population groups that are at risk. In iron-deficient infants and children, there is convincing evidence of impaired psychomotor development and cognitive.I have chosen siddha herbal formulation –Manjal noi kudineer contains Keezhanelli (Phyllanthus amarus,Shum&Thonn), karisalai (Eclipta prostrata,Linn), peipudal (Trichosanthes cucumerina,Linn), venmilagu (Piper cubeba,Linn), Sombu (Foeniculum vulgare,Mill), vilvam (Aegle marmelos,Linn). OBJECTIVE: PRIMARY OBJECTIVE: • To evaluate the efficacy of Manjal noi kudineer in the management of Paandu noi (IDA) in paediatric population.

OBJECTIVE: PRIMARY OBJECTIVE: • To evaluate the efficacy of Manjal noi kudineer in the management of Paandu noi (IDA) in paediatric population.

STUDY DESIGN: This is an interventional study of Non randomized sampling which will be carried out for 18 months in patients with hemoglobin level of 8.0-10.9 gm  reporting at OPD of Ayothidoss Pandithar Hospital , National Institute Of Siddha, Chennai-600047 with 30 patients as sample size. Patient with age 3-12 years of both sex.

 OUTCOME: PRIMARY OUTCOME:- • Primary outcome of the clinical study will be assessed by increase of hemoglobin (Hb) level in before &after treatment. • For clinical significance defined as the MCID of hemoglobin (Hb) increase from the baseline. SECONDARY OUTCOME: Reduction of clinical symptoms like malaise, headache, palpitation, lack of concentration during before and after treatment.

RESULT AND DISCUSSION: The result will be statistically analysed and reported.

KEYWORDS: anemia, manjal noi kudineer, hemoglobin.

 
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